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10 Forman, Bennett, Stafford and Dollil (1985) have estimated the number of future cases of VCM- related ASL by analysing the 110 cases diagnosed at the time, in terms of latency, and assuming that the hazard was eliminated in the late 1970's. They estimate that a further 155 cases might occur for latencies of less than 35 years. In the absence of data for latencies > 35 years they suggest that there might be around 50 cases for these extended latency periods. Thus the total estimate for all cases (recorded + future) is in the range of 200-250. In March 1993 there were 160 cases recorded in the ASL register. There has been no case of ASL recorded in any individual who has been exposed since the levels of VCM in the atmosphere were drastically reduced after 1974. The ASL register does, however, NOT contain information about the "VCM case" in former "Eastern Bloc" countries. 2.7. Regulatory measures The following table gives the historical evolution of occupational exposure limits in Europe and the USA : Year Authority Limit (ppm) 1954 ACGIH 500 1962 ACGIH 500 1971 OSHA 500 1972 ACGIH 200 1973 UK - HSE 25 (TWA-8h), 50 max. 1974 (April) OSHA 50, temporary emergency standard over 8 h i + 1974 OSHA an per oc proposed "not-detectable" level 1975 (April) OSHA 1, averaged over 8 h period with a max. of 5 for 15 min. ~ 1976 hK - HSE 10 (TWA-8h), 30 max. 1978 EEC 3, technical long-term (1yr) limit, with 7 as TWA-8h and 8 TWA-Ih 1980 AC6IH 5

11 3. Personal Conclusions The Graph shows clearly the rather linear dose/effect relation at high exposure levels and demonstrates that the technological improvements in the mid 70's have eliminated the danger for exposed workers in VCM/PVC plants. At low exposure levels the concept of linearity does not seem to be supported by either epidemiological or metabolism data - unless we can clarify reasons for the choice between detoxifying and carcinogenic metabolic pathways of VCM. The "one molecule can kill"-theory is not supported by any facts. .

12 BI BLIOGRAPFiY 1. Filatova V.S. and Gronsberg E.S. :"Hygienic working conditions in production of PVC resins and measures for improvement." Cig. Sanit. 1, 38-42 (1957) 2. Cordier J.M. et al. :"Acro-ostdolyse et lesions cutandes assocides chez deux ouvriers affectds au nettoyage d'autoclaves." Cah. Med. Trav., 4, 3-39 (1966) 3. Suciu I., et al. : "Contributti la studint imbolnavirilor produce de chlorura de vinil." Med. Interna. J5_, 967-78, (1963) 4. Viola P.L. : "Pathology of vinyl chloride". Med. lav. 61, 174 (1970) 5. Viola P.L. et al. : "Oncogenic response of rat skin, lungs and bones to vinyl chloride." Cancer Res. }1, 516-22, (1971) 6. Maltoni C. and M.A. Mehlman : "Archives of Research on Industrial Carcinogenesis." Princeton Scientific Publishers Vol. II (1984) 7. Maltoni C. et al. ."Vinyl chloride carcinogenesis : current results and perspectives" Med. Lav. 55, 421 (1974). 8. Creech J.L. and Johnson M.N. : "Angiosarcoma of the liver in the manufacture of PVC." J. Occup. Med. 16, 150-151, (1974) 9. Barnes A.W. : "Vinyl chloride and the production of PVC" Proc. Roy. Soc. Med. §1, 277-281, (1976) 10. Norsk Hydro a.s. "PVC and the environment", Oslo, (1992) 11. Freiesleben W. "Responsibility of Chemical Industry in Occupational Health Risks." Proc. 4th International Medichem Conf., Haifa (1976) p. 180 12. ECETOC Techn. Report Nr. 31 : "The mutagenicity and carcinogenicity of vinyl chloride : a historical review and assessment." Brussels, 1988, p. 7 13. Nicholson, W.J. et al. : "Mortality experience of a cohort of vinyl chloride - PVC workers." Ann. N.Y. Acad. Sci. 46, 225-280, (1975) 14. Lahmann E. et al. : "Organisch-chemische Verunreinigungen in Stadtischer Luft". Bundesgesundheitsblatt 21, 75-76 (1978) 2501171Z99

13 15. Ministerie van Volkshuisvesting, Ruimtelijke Ordering en Milieubeheer, NL (1984) 16. Til H.P. et al. : "Life-span oral carcinogenicity study of vinyl chloride in rats". TNO-CIVO report V 83.285/291099, Sept 1983 17. Barnes A.W. : "Institutional Interactions in Problems of Occupational Health : An Industry View on the Lessons from Vinyl Chloride". Proceeding 4th Intern. Conf. Medichem, Sept. 1976, Haifa 18. Unpublished communication from APME's medical working group. March 1993. 19. Watanabe P.G. et al. : "Hepatic macromolecular binding following exposure to vinyl chloride." Toxicol. Appl. Pharmacol. -44, 571 (1978) 20. Gehring P.J. et al. : "Resolution of dose-response toxicty data for chemicals requiring metabolic activation." Toxicol. Appl. Pharmacol. 44, 581-591, (1978) 21. Buchter A. et al. : "Pharmakokinetik und Karziongenese von Vinylchlorid." Verhandlung der Deutschen Gesellschaft fur Arbeitsmedizin 1$, 111-124, (1978).and Toxicol. Letters 6, 3-36 (1980) 22. Fontian D. et al. :"Exposure to vinyl chloride and angiosarocna of the liver : a report of the regi~ster of cases." 'Bi.-it. J. Indust. Nied. 42, 750-.753 (1985)

DOSE/EFFECT RELATIONS FOR VCM Exposure . levels 1992,, 20 mio t/a ( m) pp 400 Number ol: / 10 i 1 -, o t m a A5t cases/ ear ~ y 4 (according to 0 l PVC production date of diagnosis) '• ~ •. 300 15 pxposure 1evelsr / f l e or 0 1 Sca 200 -4-- 10 100 4-- 5 Mortality predictions 1976 (Barnes) 1950 1960 1970 1980 1990 I:P.IEz 1111, ," W4W Ittil::T~ rnin. latency 1(me M1L1105Z